Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Herbal and Botanical

Orange

Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.

Fluorescein

Robert H Andtbacka, MD

The purpose of this research study is to use two different drugs to find where melanoma might spread and to remove these tissues. We believe that tumor cells from the melanoma first move through the lymphatic system (a system of clear fluid that moves around the body and carries white blood cells, much like the blood system) to a lymph node in an orderly way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can detect about 90% of the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive compound and can be detected through the skin by a special instrument that reads radioactivity. As part of this research, we would like to use a second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph nodes or additional ones and examine these. This drug is fluorescent and can be detected even through the skin using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely used in people for many years. In this study, we will be injecting it under the skin, which is a different use from how it is currently approved by the FDA. In the past another drug has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is currently limited, and it has higher risks associated with it.

This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and at University of Utah. This study is a Phase I/II and is done to find out if the drug can be used safely when given under the skin and if it will work for this purpose.

OBJECTIVES:

The primary goal of this study is to evaluate the ability of intradermal fluorescein to detect sentinel lymph nodes (SLNs) in patients with stage I and stage II melanoma.

Primary Objectives To determine the co-localization between fluorescein and technetium-99m labeled sulfur colloid in SLNs.

Secondary Objectives

1. To evaluate the toxicity and safety of intradermal fluorescein injections.

The management of regional lymph nodes in patients with clinically localized primary melanomas has been controversial. An elective lymph node dissection at the time of removal of the primary melanoma has been favored by many. The proponents of elective lymph node dissection has based their opinion of the hypothesis that melanoma spreads in an orderly fashion from the primary site to regional lymph nodes and then systemically. Thus early removal of lymph node tumor deposits may prevent subsequent systemic dissemination.1-7 Four prospective randomized trials of elective lymphadenectomy have tested this hypothesis.8-11 In all of these trials, elective lymphadenectomy did not result in a significant survival benefit. In one of the trials8, a subgroup analysis indicated that elective lymphadenectomy may benefit patients younger than 60 years of age, especially those with nonulcerated primary melanomas and melanomas between 1-2mm in thickness. Based on these results, elective lymphadenectomy for patients with stage I and II melanoma is not advocated and this has resulted in a more selective evaluation of the regional lymph nodes and development of the sentinel lymph node biopsy (SLNB) technique.

The sentinel lymph node (SLN) concept is based on the hypothesis that tumor cells from primary melanomas metastasizes through the lymphatic system to regional lymph nodes in an orderly fashion and that mapping of the lymphatic system can identify the first or "sentinel" lymph node to receive metastatic tumor cells. This sentinel lymph node will become involved with metastasis before any other node in the regional lymph node basis and if involved will reflect the pathologic status of the entire regional nodal basin. Morton et al.12 were the first to evaluate the SLN concept in patients with stage I melanoma. In this study of 237 lymph node basins in 233 patients, the SLN was identified 82% of the time and it predicted the pathologic status of the nodal basin in 99% of cases. Since this preliminary study, substantial progress has been made improving and standardizing the techniques for lymphatic mapping and SLNB.

Use of a vital blue dye such as 1% isosulfan blue (Lymphazurin®) has been part of the lymphatic mapping and SLNB since its introduction. At the time of operation, 3-5 ml of the vital blue dye is injected intradermally around the intact primary melanoma or the tumor biopsy site. The dye rapidly diffuses into the lymphatic system and is carried by afferent lymphatic trunks to the SLN. An incision is made over the draining nodal basin and the blue afferent lymphatic channels are followed to the first draining lymph node(s), the sentinel lymph nodes. With the use of a vital blue dye, the SLN can be identified in approximately 87% of cases.13 This leaves 13% of patients unable to benefit from a SLN evaluation. Gershenwald et al. demonstrated that SLN identification improved from 87% to 99% when technetium-99m labeled sulfur colloid was combined with the vital blue dye. 13 To increase the detection rate of SLNs, two additional techniques are commonly used: a) pre-operative lymphoscintigraphy using a technetium-99m labeled sulfur colloid or human albumin radiotracer 14, 15 to better delineate the lymphatic drainage and identify multiple drainage basins and b) intraoperative use of a handheld gamma probe to better localize the SLN. Currently, using the vital blue dye technique in combination with a radiotracer identifies the SLN in up to 99% of cases.13, 16, 17 Based on these findings, most clinicians now recommend using a combined modality approach which is considered the "gold standard" for SLN localization in patients with primary melanoma. Although the technetium-99m labeled sulfur colloid adds a greater detection ability, formal studies have not been reported using this alone. Informal observation finds that one can pick up radioactivity in nodes which are not blue more often than one picks up blue nodes that are not radioactive, but again the ideal situation is to be able to use two tracers at once.

Although 1% isosulfan vital blue dye increases the detection of SLNs when combined with a radiotracer, it has several drawbacks. First, the dye can diffuse throughout the operative wounds making dissection and SLN identification difficult. This is especially concerning if the afferent lymphatic channels are cut. Second, 1% isosulfan blue dye has been associated with an anaphylactoid reaction or a life threatening anaphylactic shock in 0.1 - 2% of patients undergoing lymphatic mapping and SLNB.18-23 Third, a recent shortage in 1% isosulfan blue has resulted in a decreased access to the compound for patients and clinicians. Thus, there is a great need to develop new lymphatic mapping and SLN identification techniques.

Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions.24 Intravenous fluorescein is used in vascular surgery to measure vascular perfusion25 and in skin and melanoma surgery to assess the viability of skin flaps.26, 27 Intradermal fluorescein injections have been used to identify pedal lymphatics to facilitate lymphangiography.28 This study was designed to look at both the safety and efficacy of using 10% fluorescein mixed 1:1 with 1% lidocaine hydrochloride. Cooper et al. reported on intradermal injection of fluorescein in 1,047 patients without adverse reactions.28 In this study, "not a single immunologic reaction was identified. In two patients, local skin sloughing occurred at the injection site due to inadvertent administration of a 3;1 fluorescein-lidocaine mixture rather than the prescribed 1:1 ratio". Dan et al.29 used intramural bowel injection of fluorescein in 120 patients with colon cancer to map the lymphatics in patients with colon cancer. Fluorescein was able to identify the sentinel lymph node in 97% of patients and none of the 120 patients suffered any adverse reactions. We have previously shown that Cy5-cobolamine bioconjugate injected intradermally into the hind limb of pigs is able to identify inguinal sentinel lymph nodes.30 More recently, we have also determined that fluorescein injected intradermally into the limb of pigs is also able to identify the sentinel lymph node. Additionally, when 1% isosulfan blue is injected in the same location as fluorescein, the two detection techniques co-localizes in the afferent lymphatics and the sentinel lymph node. The fluorescent signal from fluorescein provides improved detection of the afferent lymphatic and the sentinel lymph node compared to 1% isosulfan blue. Moreover, fluorescein fluorescence is clearly visualized transdermally and enables an improved localization of the sentinel lymph node prior to performing a skin incision. (Andtbacka RH, McGreevy JM, Grissom CB et al. unpublished results). This transdermal fluorescence may enable elimination of the radiotracer in sentinel lymph node detection. Based on these findings we are now proposing a phase I/II clinical trial in melanoma to assess the safety and feasibility of intradermal fluorescein in the detection of SLNs in patients with stage I and stage II melanoma.

10 patients were enrolled in the Phase 1 portion of the trial. 80 patients were enrolled in the Phase 2 portion of the trial. 90 patients were enrolled total for the Phase 1 and 2 portions. Results are reported for the 80 patients on the Phase 2 portion.

Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma

Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma

There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.

Number of participants that experienced an adverse event

University of Utah

All Adverse Events are reported - none were considered related to the investigational product.

Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.

Phase I/II Patients

All participants enrolled.

Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.

All Patients

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Mark Wade

Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.

Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.

Total number of patients with at least one SLN was 89

Percentage of Agreement Between the Detection of SLNs

Adverse Event Recorded

Adverse Events Related to Study Treatment

Safety Evaluation of Intradermal Fluorescein Injections.

Overall Study

Nervous System Diseases

Heart and Blood Diseases

Stroke

Epilepsy

Brain Diseases

Central Nervous System Diseases

High-density EEG will be used for brain localization in epilepsy patients

High-density EEG will be used for brain localization in healthy controls

High-density EEG will be used for brain localization in tumor patients

High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction

High-density EEG will be used for brain localization in patients who have recently experienced a stroke

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density electroencephalogram (HD-EEG)

The purpose of the study is to use a new method of high-density electroencephalogram (HD-EEG) recording to map brain areas important for movement, sensation, language, emotion, and cognition.

This study will measure brain waves using high-density EEG. Participants will be asked wear a cap with electrodes attached to it. During the recording, participants may be asked to rest, sleep, or complete a task. The tasks involve viewing pictures, answering questions, speaking, or moving an arm or leg. Recordings generally last between 60-120 minutes.\*

High-density EEG in Neurological Disorders

Localize brain functions using high-density EEG recordings

Localize brain areas involved in language using high-density EEG recordings

Localize brain areas involved in movement using high-density EEG recordings

Localize brain areas involved in sensation using high-density EEG recordings

Localize brain areas involved in emotion using high-density EEG recordings

Localize brain areas involved in memory using high-density EEG recordings

Localize brain areas associated with lesions using high-density EEG recordings

Dartmouth-Hitchcock Medical Center

Clinical Neurophysiologist, Neuro Diagnostics

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Central Nervous System Depressants

Anesthetics

Those patients' Multiparametric Prostate Magnetic Resonance (MPMR) imaging's have been assessed by a genitourinary radiologist to guide the surgeon who performs cognitive prostate biopsy

Those patients' Multiparametric Prostate Magnetic Resonance (MPMR) imaging's have not been assessed by a genitourinary radiologist to guide the surgeon who performs cognitive prostate biopsy. Surgeon assesses the Multiparametric Prostate Magnetic Resonance (MPMR) imaging's by him/herself

All patients will undergo prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after mapping extracted by a single genitourinary radiologist in the Department of Radiology of our hospital.

Performing cognitive prostate biopsy with a radiologist's guidance with map

All patients will undergo cognitive prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after reported by a single genitourinary radiologist in the Department of Radiology of our hospital.

Performing cognitive prostate biopsy without a radiologist's guidance with map

Yunus Emre Genc, MD.

Haydar Kamil Cam, Professor

Murat Kars, M.D.

Haydar Kamil Cam, Prof.

Today, many centers still perform Magnetic Resonance Imaging (MRI) cognitive prostate biopsy. The efficacy of detecting clinically significant prostate cancer, which is thought to be due to the experience of the urologist who performed the sampling and the difference in experience of the radiologists who performed the Multiparametric Prostate Magnetic Resonance (MPMR) evaluation, has been reported between 25% and 34% in the literature.

In order to eliminate this reporting and sampling difference, The goal of this interventional study is to compare the effectiveness of Multiparametric Prostate Magnetic Resonance (MPMR) Imaging routinely taken before biopsy with a single-center randomized and prospective study and prostate biopsies to be performed by the same urologist with the mapping technique created by a single genitourinary radiologist working in our center with standard cognitive prostate biopsy and to contribute to the literature Type of study: Clinical trial participant population: Male patients with elevated serum Prostate Specific Antigen (PSA) or indicated prostate biopsy by Magnetic Resonance Imaging (MRI) imaging and underwent Multiparametric Prostate Magnetic Resonance (MPMR) before the procedure Participants will undergo transrectal prostate biopsy with or without mapping, Researches will compare to see if the cancer detection rates differ

In this preliminary clinical study, 200 patients who underwent cognitive prostate biopsy under the guidance of transrectal ultrasonography between 01.03.2023 and 01.09.2023 by Marmara University Department of Urology, Department of Urooncology due to serum Prostate Specific Antigen (PSA) elevation and/or abnormal rectal examination findings will be included in the study. All patients will undergo prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after mapping or report is extracted by a single genitourinary radiologist in the Department of Radiology of our hospital.

In the power analysis, 200 patients were included in the study with the prediction that the efficacy difference would be calculated as 5%. All patients will be randomized to two equal groups by the flip-flip method.

1. Multiparametric Prostate Magnetic Resonance Imaging and reports of the mapped patients will be examined and cognitive prostate biopsy will be performed by looking at the map (Sample Figure 1,2) created by the same urologist and the same radiologist (Sample Figure 1,2). Standard 12 core (6 peripheral zones from both lobes) will be sampled and 4 extra biopsies will be taken from Prostate Imaging-Reporting and Data System (PI-RADS) Category 3-4-5 areas in the mapping.
2. Based on the Multiparametric Prostate Magnetic Resonance Imaging reports and images, without mapping by the radiologist, only the standard 12 core (6 from each peripheral zone from both lobes) determined cognitively by the urologist and 4 extra biopsies from the Prostate Imaging-Reporting and Data System (PI-RADS) Category 3-4-5 areas described in the report will be taken.

And then the biopsy results will be compared to see the efficacy of mapping

The Efficacy Of Mapping For Cognitive Prostate Biopsy

The Efficacy Of Mapping For Cognitive Prostate Biopsy: A Prospective, Randomized Study

Detection of any kind or any grade of prostate cancer on the pathological specimen of Transrectal Ultrasound Guided Prostate Biopsy:

* Detection of prostate adenocarcinoma of any ISUP (grade 1, grade 2, grade 3, grade 4 or grade 5) / Gleason score (Gleason score 6-10)
* Detection of non-adenocarcinoma cancers of prostate (small cell carcinoma, neuroendocrine tumor, sarcomatous carcinoma, signet ring cell, basaloid carcinoma, pseudohyperplastic carcinoma, lymphoepithelioma-like carcinoma, adenosquamous cell carcinoma)

Marmara University

Symptoms and General Pathology

Blood and Lymph Conditions

Breast Neoplasms

Recurrence

Lymphedema

Breast Diseases

Lymphatic Diseases

Patients receive isosulfan blue SC and undergo ALND.

Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.

Isosulfan Blue

Axillary Lymph Node Dissection

Mapping

Quality-of-Life Assessment

Questionnaire Administration

V. Suzanne Klimberg, MD, PhD

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

PRIMARY OBJECTIVES:

I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping \[ARM\]) versus Group II (ARM).

SECONDARY OBJECTIVES:

I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).

II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.

III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.

EXPLORATORY OBJECTIVES:

I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).

GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.

After completion of study, patients are followed up for 3 years.

Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping

Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire contains two different scales for intensity and distress measured from 1 (slight) to 5 (severe). The LSIDS-A questionnaire scores for swelling in the arm, decreased physical activity, pain in the arm, and loss of confidence in one's body will be evaluated for the change of baseline to 36 months using a two-sample, two-sided t-test.

Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire scores at each time point, as well as the change from baseline will be compared between groups by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), will use a non-parametric procedure such as Wilcoxon rank sum test. Further analysis will include linear mixed model using data from all time points to compare the LSIDS-A questionnaire scores between the two treatment groups over time adjusting for other baseline characteristics. Will evaluate the pattern of missing data. If the drop-out rate is higher than expected, methods proposed by Hogan and Laird will be used to assess whether the presence of drop-outs affects inferences obtained from the repeated measures analyses. Appropriate methods will be used to address missingness.

The technical success will be summarized using a binomial point estimate and 95% confidence interval (CI) and will be compared using a two-sample test of proportions.

The cumulative incidence of regional recurrence will be summarized using the cumulative incidence function treating death without regional recurrence as the competing risk. Similar analysis methods described for the primary endpoint will be used to compare the cumulative incidence of regional recurrence between group I and II.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma	NCT00847522	Cancer	Fluorescein	18 Years -	University of Utah
Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma	NCT00847522	Cancer	Fluorescein	18 Years -	University of Utah
High-density EEG in Neurological Disorders	NCT04266041	Epilepsy Tumor Healthy	High-density el...	18 Years -	Dartmouth-Hitchcock Medical Center
Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma	NCT00847522	Cancer	Fluorescein	18 Years -	University of Utah
The Efficacy Of Mapping For Cognitive Prostate Biopsy	NCT05902637	Prostate Cancer Prostate Adenoc... Prostatic Neopl... Prostate Diseas... Prostate Cancer...	Performing cogn... Performing cogn...	40 Years - 90 Years	Marmara University
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection	NCT03927027	Breast Cancer S... Breast Cancer S... Breast Cancer S...	Isosulfan Blue Axillary Lymph ... Mapping Quality-of-Life... Questionnaire A...	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for mapping

Every month we try and update this database with for mapping cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mapping

Every month we try and update this database with for mapping cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mapping cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.